Status:
COMPLETED
A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above
Lead Sponsor:
China National Biotec Group Company Limited
Collaborating Sponsors:
G42 Healthcare company
Abu Dhabi Health Services Company
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines i...
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 yea...
Eligibility Criteria
Inclusion
- Healthy subjects aged 18 years old and above.
- By asking for medical history and physical examination, the investigator judged that the health condition is well.
- Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 3 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
- During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan.
- With self-ability to understand the study procedures, the informed consent \& voluntarily sign an informed consent form and be able to comply with the requirements of the clinical study protocol.
Exclusion
- Confirmed acute cases of SARS-CoV-2 Infection.
- Have a history of SARS, MERS infection (self-report, on-site inquiry).
- Positive urine pregnancy test result.
- Fever (body temperature \> 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination.
- Axillary body temperature \> 37.0 ℃ before vaccination.
- Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred.
- Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history.
- With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- With severe liver diseases, severe kidney diseases defined as eGFR less than 60, uncontrollable hypertension (systolic blood pressure \>150 mmHg, diastolic blood pressure \> 90 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases.
- Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases.
- With known or suspected diseases include acute respiratory diseases (e.g. influenza like illness, acute cough, sore throat), severe cardiovascular diseases, liver and kidney diseases, and malignant tumors.
- Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease).
- Receiving anti-TB therapy.
- Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days).
- Live attenuated vaccine is inoculated within 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination.
- Received blood products within 3 months before this vaccination
- Received other research drugs within 6 months before this vaccination.
- Other circumstances judged by investigators that are not suitable for this clinical trial.
Key Trial Info
Start Date :
July 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
44101 Patients enrolled
Trial Details
Trial ID
NCT04510207
Start Date
July 16 2020
End Date
December 31 2021
Last Update
June 18 2023
Active Locations (6)
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1
Bahrain International Exhibition & Convention Centre Affiliated to Salymynia Medical Complex S
Sanābis, Bahrain
2
Katameya Medical Center
Cairo, Egypt, 11835
3
Vacsera health Care facilities , MoH
Cairo, Egypt, 22311
4
Prince Hamza Hospital
Amman, Jordan